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Fortive Corporation Quality Systems IT Analyst in Irvine, California

As a Business Systems Analyst specializing in QMS and PLM, you will play a critical role in ensuring the efficient operation and continuous improvement of our organization’s quality processes and product development lifecycle. You’ll collaborate with cross-functional teams, analyze business requirements, and drive system enhancements to optimize our QMS and PLM applications.

Duties and Responsibilities

Under limited supervision and in accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, this position has the following responsibilities:

QMS/PLM Analysis and Enhancement:

  • Examine current QMS & PLM processes and identify opportunities to improve efficiency and compliance through system controls and automation.

  • Collaborate with stakeholders to Analyze, develop, and communicate business and technical requirements for QMS & PLM systems.

  • Participate in and lead kaizens to collaboratively deep dive into QMS & PLM performance.

  • Identify and oversee the implementation of continuous improvement opportunities in the respective IT Systems.

  • Train end-users on new features and enhancements. Create communication and job aids to support adoption of new functionality.

  • Establish strategic roadmap for QMS/PLM solutions aligned with ASP strategic initiatives

  • Ensure alignment with regulatory standards (e.g., ISO 13485, 21CFR820, EU MDR, MDSAP).

System Architecture and Development:

  • Collaborate with development and support teams to design business solutions that leverage the simplest technical solution and intelligent architecture to minimize future debt and maximize re-usable components.

  • Establish user stories, business cases, and acceptance criteria to translate and break dow desired outcomes into functional layers a developer can bring to life.

  • Establish development priorities for monthly sprints, perform technical and functional reviews of developed solutions, and oversee user acceptance testing to ensure solutions meet user needs and are validated for on-time delivery.

  • Develop and maintain test cases that ensure desired functionality is maintained and future enhancements don’t cause regression issues.

Data Integration and Reporting:

  • Integrate data from various sources into QMS and PLM systems.

  • Generate regular management reports and dashboards on quality metrics.

  • Support Quality, Regulatory, R&D, and Supply Chain staff in monitoring and improving products and processes.

Responsible for communicating business-related issues or opportunities to the next management level

Performs other duties assigned as needed

Qualifications

Education:

  • Bachelor’s Degree

Years of Related Experience:

At least 3 years’ experience in the Medical Device industry or medical field with specific experience in

establishing and driving continuous improvement of quality systems and/or product lifecycle

management applications in a regulated environment.

Knowledge, Skills, Abilities, Certifications/Licenses, and Affiliations:

  • (Include any required computer skills, regulatory knowledge, certifications, licenses, languages, cognitive and behavioral abilities etc.)

  • Experience with quality/PLM system design, validation, training, and change management. Experience working with and administering Propel Software and/or Salesforce a plus.

  • Knowledgeable and experienced with understanding medical device quality system regulations and standards (e.g. ISO 13485, 21CFR820, EU MDR, MDSAP).

  • Strong verbal and written communication skills. Ability to effectively communicate and translate highly technical information in a professional manner at all levels.

  • Strong analytical skills to identify issues and troubleshoot problems.

  • Enthusiastic, highly motivated, quick learning, creative problem solving, proactive, adaptable, and curious.

  • Organized planner with project management capabilities a plus

  • Experienced and proficient with the Atlassian JIRA & Confluence a plus.

Fortive Corporation Overview

Fortive’s essential technology makes the world stronger, safer, and smarter. We accelerate transformation across a broad range of applications including environmental, health and safety compliance, industrial condition monitoring, next-generation product design, and healthcare safety solutions.

We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in software-powered workflow solutions, data-driven intelligence, AI-powered automation, and other disruptive technologies. We’re a force for progress, working alongside our customers and partners to solve challenges on a global scale, from workplace safety in the most demanding conditions to groundbreaking sustainability solutions./p>

We are a diverse team 18,000 strong, united by a dynamic, inclusive culture and energized by limitless learning and growth. We use the proven Fortive Business System (FBS) to accelerate our positive impact.

At Fortive, we believe in you. We believe in your potential—your ability to learn, grow, and make a difference.

At Fortive, we believe in us. We believe in the power of people working together to solve problems no one could solve alone.

Fortive: For you, for us, for growth.

The salary range for this position (inclusive of sales incentives/commission) is $79,700.00 - $147,900.00. Base pay offered may vary depending on various factors, including, but not limited to: job-related knowledge; skills; experience; and other eligibility factors such as geographic location. The Total Rewards package includes competitive base pay and an opportunity to enroll in a variety of benefit programs, generally including health insurance, flexible spending accounts, health savings accounts, retirement savings plans, life and disability insurance programs, and several programs that provide for both paid and unpaid time away from work.

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